FDA has reevaluated the rationale document submitted by the Clinical and Laboratory Standards Institute (CLSI) to susceptibility test interpretive criteria (STIC) docket #FDA-2017-N-5925 entitled, “Polymyxin Breakpoints […]

Amikacin Injection FDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa Antibacterial 4/21/2023 Amoxicillin and clavulanate Oral FDA does not […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs What we now call real-world data (RWD) have been used for years in medical product […]

On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab […]